What are the responsibilities and job description for the Statistician position at Aequor?
Top 3 Must Have's to be considered for this role:
2 years of statistical analysis experience in Biopharma or Phd
ICH guidelines
Stability Data, Specification
Job Description: CMC Statistician
Client Hybrid role, Devens OR New Brunswick site
Work Schedule: Mon - Fri, Business hours
This position is responsible for providing statistical analysis to service clients in Global Product Development & Supply (GPS).
Major Duties and Responsibilities:
The successful candidate will provide statistical support to Global Product Development & Supply (GPS) in Analytical Strategy & Operations and Manufacturing Science & Technology to ensure product quality, process productivity, robustness, and compliance.
Areas of support include stability analysis, specification setting, statistical application in manufacturing processes, health authority filings, and regulatory responses.
This role offers the opportunity to support the Client product portfolio worldwide with functions in small molecule and biologics development, manufacturing, and supply.
Key Requirements:
None
2 years of statistical analysis experience in Biopharma or Phd
ICH guidelines
Stability Data, Specification
Job Description: CMC Statistician
Client Hybrid role, Devens OR New Brunswick site
Work Schedule: Mon - Fri, Business hours
This position is responsible for providing statistical analysis to service clients in Global Product Development & Supply (GPS).
Major Duties and Responsibilities:
The successful candidate will provide statistical support to Global Product Development & Supply (GPS) in Analytical Strategy & Operations and Manufacturing Science & Technology to ensure product quality, process productivity, robustness, and compliance.
Areas of support include stability analysis, specification setting, statistical application in manufacturing processes, health authority filings, and regulatory responses.
This role offers the opportunity to support the Client product portfolio worldwide with functions in small molecule and biologics development, manufacturing, and supply.
Key Requirements:
- Extensive knowledge of statistical methodologies, including regression, ANCOVA, Monte Carlo simulation,
- Familiar with or able to develop an understanding of pharmaceutical stability data and how it is generated and
- General familiarity with the types of chemical/biochemical analyses, the data variability, and good manufacturing
- Able to help in the design of stability studies using matrixing and bracketing (ICH stability guidance Q1D) and,
- Knowledge of pharmaceutical product shelf-life and specification.
- Experience in extracting data from a variety of sources, databases, and documents.
- Good communication, presentation, and technical writing skills.
- Ability to effectively communicate and explain statistical technical information to non-statistician colleagues.
- Ability to work independently as well as effectively collaborate with cross-functional teams.
- M. S. with a minimum of 2 years' experience or Ph. D. in Statistics, Applied Mathematics, Data Science, or
- Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS).
- Knowledge and experience in pharmaceutical or biotechnology industries.
- Familiarity with Bayesian statistics.
- Some background in sciences to facilitate a subjective understanding of the problems.
- Experience in working with a wide range of technically and culturally diverse individuals.
- 2 years of statistical analysis experience in Biopharma or Phd
- ICH guidelines
- Stability Data, Specification
None
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